FDA warns medical groups about chemical in plastic

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FDA warns medical groups about chemical in plastic

Last Updated: 2002-07-16 17:01:35 -0400 (Reuters Health)

WASHINGTON (Reuters Health) - The US Food and Drug Administration (FDA) told

medical professional societies on Monday that certain devices may expose

people to a toxic dose of a plastic-softening chemical called DEHP.

In a letter to medical professional societies, the agency says DEHP might be

found in IV bags and tubing, blood bags, nasogastric tubes, dialysis bags

and tubing, and other tubing used to support and feed premature infants.

Newborns are likely to get the highest exposure to DEHP, through procedures

like exchange transfusion, total parenteral nutrition, and extracorporeal

membrane oxygenation, said the agency. Adolescent boys and pregnant or

nursing women who receive dialysis are also at risk for toxic exposure, as

are heart transplant recipients, people who get bypass surgery, or large

amounts of blood replacement after trauma.

If available, alternatives should be used, according to the federal agency.

The letter follows up on an FDA study of DEHP safety, issued in September.

DEHP (di(2-ethylhexyl) phthalate) is a chemical used to soften plastic,

mostly polyvinyl chloride (PVC). DEHP is a type of phthalate, a family of

chemical compounds often used in plastic manufacturing.

The advocacy group Health Care Without Harm petitioned the FDA to

investigate DEHP's use in devices. The Washington DC-based organization

wants phthalates phased out or removed from cosmetics, toys and other

consumer goods, saying they're toxic to animals' reproductive systems and

their early development.

An expert panel convened by National Institute of Environmental Health

Sciences' National Toxicology Program reached the same conclusion in 2000,

and said that it hoped manufacturers would develop DEHP-free medical devices

for use in infants, who seem to be particularly at risk.

The FDA also found DEHP potentially harmful to humans, especially to

development of young men's reproductive systems. Animal studies also showed

damage to sperm production.

No human studies have been done, but the animal studies offer enough

evidence to indicate potential human harm, said Ron Brown, a toxicologist at

the FDA's Office of Science and Technology who did the safety study.

The study was posted on FDA's Web site, but no correspondence was sent until

now because " we needed time to assess what the advice should be, " said FDA

spokeswoman Sharon Stone.

The FDA does not require device makers to say if products contain DEHP,

which angers Charlotte Brody, president of Health Care Without Harm.

Healthcare providers " have to be able to look at the product and see whether

it contains DEHP, " Brody told Reuters Health. Her group has been working

with hospitals to find devices made without DEHP, and several large group

purchasing organizations do offer DEHP-free alternatives for their members.

The University of Massachusetts at Lowell also has a database of DEHP-free

devices.

The FDA said it recommends DEHP-free devices when the listed high-risk

procedures will be done on male infants, pregnant women who have male

fetuses, and adolescent boys.

However, said the agency, the procedures should not be avoided " simply

because of the possibility of health risks, " adding that " the risk of not

doing a needed procedure is far greater than the risk associated with

exposure to DEHP. "

In a statement, AdvaMed, a trade group for medical device manufacturers,

agreed with the FDA's caution on risks and benefits, claiming that the FDA's

safety assessment concluded that " there is 'little to no risk' to patients

associated with the vast majority of DEHP-plasticized medical devices. "

Copyright © 2002 Reuters Limited.